Site Contracts and Budget Manager

🔥 1 hour ago

🌐 Hungary, Poland, +3 more countries – Remote

🇭🇺 Hungary – Remote 🇵🇱 Poland – Remote 🇸🇰 Slovakia – Remote 🇷🇸 Serbia – Remote 🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 21%

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Develop global clinical trial budget templates from complex protocols and study documentation • Review protocols, amendments, SoAs, manuals, and study documents to identify site-level cost implications • Translate protocol requirements into detailed global/site budget templates • Map procedures and activities to study visits and payment milestones • Develop per-patient, per-visit, conditional, invoiceable, and one-time study costs • Identify site start-up, pharmacy, laboratory, imaging, archiving, maintenance, close-out, screen-failure, unscheduled-visit, participant reimbursement/travel, institutional/overhead, pass-through, and invoiceable costs • Ensure budget structures support payment terms and CTA exhibits • Incorporate country-specific cost information and benchmarks into budget templates • Establish negotiation targets, parameters, and escalation pathways • Perform detailed quality control of budget templates before release to SCM negotiators • Confirm consistency between protocol/SoA requirements and completed budgets and document assumptions • Maintain version control and auditable budget-development records • Assess financial impacts of protocol amendments and update budget templates • Serve as a budget-development subject matter expert for SCM and study teams • Support standardization of templates, tools, SOPs, work instructions, and training • Identify automation and efficiency opportunities • Review, draft, negotiate, and track clinical, site, vendor, confidentiality, and other contracts • Resolve or escalate contractual issues with internal and external stakeholders • Ensure adherence to contracting policies, procedures, and standards • Track and report site contract metrics and maintain contract files and databases • Support timely contract execution and process improvements • Perform other assigned tasks

🎯 Requirements

• Graduate, postgraduate, or 4-year college degree • Experience in a CRO, pharmaceutical, biotechnology, or healthcare environment • At least 5 years of relevant clinical research experience, including substantial hands-on experience developing investigator/site budget templates • Demonstrated experience developing global and/or multi-country clinical trial budget templates for sponsor- or CRO-managed studies • Strong ability to interpret complex protocols, SoAs, amendments, and supporting study documents and translate requirements into complete site-level costs • Experience using country-specific cost information and/or benchmarking data to develop budget assumptions and negotiation parameters • Knowledge of CTA budget exhibits, clinical trial payment terms, and site budget negotiation processes • Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements, Vendor Contracts and Site Budget negotiations • Experience leading interactions with Study Teams and Sponsors • Experience with oncology and/or other complex clinical trial protocols • Proficient in MS Office software programs and computer applications • Ability to work independently and cooperatively in a virtual environment • Candidates must be legally authorized to work in the country of employment without employer sponsorship. • Preferred: Bachelors in scientific fields, business administration or equivalent degree • Preferred: Excellent organizational and communication skills and attention to detail • Preferred: Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines.

🏖️ Benefits

• Fully remote work arrangement • Regular full-time employment

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